A Study to Evaluate ALN-6400 in Adult Healthy Volunteers

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: ALN-6400; Drug: Placebo

• Registration Number: NCT06659640
• Lead Sponsor: Alnylam Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Study Start: 2024-11-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-09-10
• Study Completion: 2026-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALN-6400	ALN-6400	Participants will be administered a single dose of ALN-6400.
Placebo	Placebo	Participants will be administered a single dose of placebo.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	Up to 36 weeks

Secondary Outcome Measures

Name	Time	Method
Concentrations of ALN-6400 in Plasma	Predose and up to 2 days postdose
Change from Baseline in the ALN-6400 Target in Plasma	Predose and up to 36 weeks postdose

Trial Locations

Locations (1)

Clinical Trial Site; 🇨🇦 Montreal, Canada